Understanding brain changes in patients with neurotoxicity from CAR T-cell therapy
Official title: Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
Run by Hebei Medical University · NCT05643092 · Data updated 2026-11-12
This study is trying to understand how CAR T-cell therapy affects the brain in patients who develop neurotoxicity, by looking at brain scans and certain chemicals in their spinal fluid.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Hebei Medical University Academic / other |
| Drugs / interventions | CAR T, CAR-T |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Status | Recruiting |
| Started | March 6, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | March 7, 2023 |
| Trial ID | NCT05643092 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are scheduled to receive CAR T-cell treatment.
✕Probably not a fit
Patients who have previously undergone CAR T-cell therapy or have significant neurological conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the brain mechanisms disrupted in patients experiencing Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) following CAR T-cell therapy. It will measure levels of catecholamines in cerebrospinal fluid and utilize multimodal magnetic resonance imaging to assess brain changes in these patients. By identifying specific biomarkers and imaging characteristics associated with ICANS, the study seeks to enhance detection and prevention strategies for this complication.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of neurotoxicity in patients undergoing CAR T-cell therapy.
How similar studies have gone: While the specific approach of this study is novel, previous studies have indicated the importance of understanding neurotoxicity in CAR T-cell therapy, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be ≥ 18 years of age at signing of informed consent. * Subjects are scheduled to receive CAR T-cell treatment. Exclusion Criteria: * Refusal to sign the informed consent * Subjects having previously been treated with CAR-T therapy. * Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding * Subjects presenting primary CNS lymphoma * Pacemaker or other implanted electrical device incompatible with the MR environment * Subjects with a neurodegenerative disease (PD, AD) * Subjects with a previous or evolving neurological pathology * Pregnant or breastfeeding women
Where it's running
-
980th Hospital
Shijiazhuang, Hebei, China Recruiting
Study contacts
- Principal investigator: Shoulong Zhang — 980th Hospital
- Study coordinator: Shoulong Zhang
- Email: longer_human007@126.com
- Phone: 86-0311-98224
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Seeing if DCog Short on an iPad can spot neurotoxicity in CAR-T patients
This study tests whether a self-report iPad tool called DCog Short can help identify neurotoxicity in people receiving CAR-T cell therapy.
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Remote rehabilitation for people receiving CAR-T cell therapy
This project will test a home-based telerehabilitation program using interactive exercise, nutrition, behavioral support, and remote monitoring for people with lymphoma or myeloma who are getting CAR-T therapy.
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Characterizing extracellular vesicles and blood–brain barrier changes during CAR‑T therapy to understand ICANS
This research will try to see if tracking extracellular vesicles in blood and MRI markers of blood–brain barrier change can help detect or explain ICANS in adults receiving CAR‑T cell therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.